ASTAGRAF XL Drug Patent Profile

When do Astagraf Xl patents expire, and when can generic versions of Astagraf Xl launch?

Astagraf Xl is a drug marketed by Astellas and is included in one NDA.

The generic ingredient in ASTAGRAF XL is tacrolimus. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Astagraf Xl

A generic version of ASTAGRAF XL was approved as tacrolimus by SANDOZ on August 10^th, 2009.

Summary for ASTAGRAF XL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	9
Drug Prices:	Drug price information for ASTAGRAF XL
What excipients (inactive ingredients) are in ASTAGRAF XL?	ASTAGRAF XL excipients list
DailyMed Link:	ASTAGRAF XL at DailyMed

See drug prices for ASTAGRAF XL

Recent Clinical Trials for ASTAGRAF XL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Colorado, Denver	Early Phase 1
Cedars-Sinai Medical Center	Phase 4
Medical University of South Carolina	Phase 4

See all ASTAGRAF XL clinical trials

Pharmacology for ASTAGRAF XL

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors

Paragraph IV (Patent) Challenges for ASTAGRAF XL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ASTAGRAF XL	Extended-release Capsules	tacrolimus	0.5 mg, 1 mg, and 5 mg	204096	1	2013-09-24

US Patents and Regulatory Information for ASTAGRAF XL

ASTAGRAF XL is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-001	Jul 19, 2013	AB	RX	Yes	No
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	AB	RX	Yes	No
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	AB	RX	Yes	Yes

Expired US Patents for ASTAGRAF XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	6,576,259
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	6,440,458
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	6,440,458
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-001	Jul 19, 2013	6,440,458
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	6,884,433

EU/EMA Drug Approvals for ASTAGRAF XL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Astellas Pharma Europe B.V.	Modigraf	tacrolimus	EMEA/H/C/000954 Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.	Authorised	no	no	no	2009-05-15
Astellas Pharma Europe BV	Advagraf	tacrolimus	EMEA/H/C/000712 Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.	Authorised	no	no	no	2007-04-23
Chiesi Farmaceutici S.p.A.	Envarsus	tacrolimus	EMEA/H/C/002655 Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.	Authorised	no	no	no	2014-07-18
LEO Pharma A/S	Protopic	tacrolimus	EMEA/H/C/000374 Flare treatmentAdults and adolescents (16 years of age and above)Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.Children (two years of age and above)Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatmentMaintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).	Authorised	no	no	no	2002-02-27
Teva B.V.	Tacforius	tacrolimus	EMEA/H/C/004435 Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.	Authorised	yes	no	no	2017-12-08

International Patents for ASTAGRAF XL

See the table below for patents covering ASTAGRAF XL around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	570814
Russian Federation	2214244	ПРЕПАРАТЫ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ (SUSTAINED-RELEASE PREPARATIONS)
Turkey	200002771
Germany	69918074
Austria	514419

ASTAGRAF XL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ASTAGRAF XL

Introduction

ASTAGRAF XL, a tacrolimus extended-release capsule, is a significant player in the immunosuppressant market, particularly for preventing organ rejection in adult kidney transplant recipients. Here, we delve into the market dynamics and financial trajectory of this drug.

Approval and Availability

ASTAGRAF XL was approved by the U.S. Food and Drug Administration (FDA) on July 19, 2013, marking a significant milestone in transplant immunology. It is the first once-daily oral tacrolimus formulation available in the U.S. for this purpose and has been approved for use in 73 countries[1][4].

Clinical Use and Dosage

ASTAGRAF XL is used in conjunction with other medications such as mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction. The recommended starting doses vary depending on whether basiliximab induction is used: 0.15 mg/kg once-daily with induction, and 0.1 mg/kg once-daily pre-operatively and 0.2 mg/kg once-daily post-operatively without induction[1][4].

Market Impact

The introduction of ASTAGRAF XL provided new adult kidney transplant recipients with an additional option for immunosuppressant care. This expansion in treatment options has been welcomed by the transplantation community, as it offers a more convenient once-daily dosing regimen compared to traditional immediate-release tacrolimus formulations[1][4].

Sales Performance

ASTAGRAF XL is part of Astellas Pharma's portfolio of major products that drive growth. While specific sales figures for ASTAGRAF XL alone are not always detailed in public reports, it is included under the broader category of PROGRAF, which also encompasses Advagraf and Graceptor. These products collectively contribute to a significant portion of Astellas' revenue.

In the fiscal year 2021, Astellas reported that products like XTANDI, XOSPATA, PADCEV, and PROGRAF (including ASTAGRAF XL) accounted for approximately 80% of the company's revenue[3].

Financial Trajectory of Astellas Pharma

Astellas Pharma's financial performance provides context for the trajectory of ASTAGRAF XL.

Revenue Growth

Astellas has seen steady revenue growth over the years. In the fiscal year ended March 31, 2021, the company reported revenue of ¥1,249.5 billion, representing a growth of over 40% from the fiscal year ended March 31, 2006[3].

Recent Financial Performance

For the first nine months of FY2023, Astellas reported a 2.1% year-on-year increase in revenue to ¥1,189.1 billion. However, core operating profit decreased by 36.0% due to various factors including increased selling, general, and administrative expenses and amortization of intangible assets[5].

Product-Specific Performance

While ASTAGRAF XL's individual sales figures are not separately reported, the overall performance of PROGRAF and other key products indicates a stable contribution to Astellas' revenue. The company's focus on innovative treatments and expanding its product portfolio has helped maintain a strong market presence[3].

Competitive Landscape

The immunosuppressant market is competitive, with several drugs available for preventing organ rejection. However, ASTAGRAF XL's once-daily dosing regimen offers a unique advantage in terms of patient compliance and convenience. This differentiation helps it maintain a competitive edge in the market[1][4].

Regulatory and Market Expansion

ASTAGRAF XL's approval in 73 countries highlights its global reach and acceptance. Astellas continues to work on expanding its product offerings and improving patient care, which is reflected in the company's strategic goals and focus areas[1][3].

Sustainability and Future Outlook

Astellas emphasizes its commitment to environmental and social sustainability, which is crucial for its business continuity. The company's vision to be at the forefront of healthcare change and to turn innovative science into value for patients aligns with the ongoing development and marketing of products like ASTAGRAF XL[3].

Key Takeaways

• Approval and Availability: ASTAGRAF XL was approved by the FDA in 2013 and is available in 73 countries.
• Clinical Use: It is used with other medications to prevent organ rejection in kidney transplant recipients.
• Market Impact: Provides a convenient once-daily dosing regimen, enhancing patient compliance.
• Sales Performance: Part of Astellas' major products driving revenue growth.
• Financial Trajectory: Astellas has seen steady revenue growth, though recent core operating profits have decreased.
• Competitive Landscape: Unique dosing regimen offers a competitive edge.
• Regulatory and Market Expansion: Global reach with approvals in 73 countries.
• Sustainability and Future Outlook: Aligns with Astellas' vision for innovative patient care and sustainability.

FAQs

What is ASTAGRAF XL used for?

ASTAGRAF XL is a prescription medicine used to help prevent organ rejection in people who have had a kidney transplant. It is used in conjunction with other medications such as mycophenolate mofetil (MMF) and corticosteroids[1][4].

When was ASTAGRAF XL approved by the FDA?

ASTAGRAF XL was approved by the U.S. Food and Drug Administration (FDA) on July 19, 2013[1][4].

What is the recommended dosage for ASTAGRAF XL?

The recommended starting dose of ASTAGRAF XL varies depending on whether basiliximab induction is used. With induction, the dose is 0.15 mg/kg once-daily. Without induction, the dose is 0.1 mg/kg once-daily pre-operatively and 0.2 mg/kg once-daily post-operatively[1][4].

How does ASTAGRAF XL differ from other tacrolimus formulations?

ASTAGRAF XL is an extended-release capsule, offering a once-daily dosing regimen, which is different from traditional immediate-release tacrolimus formulations[1][4].

What is the global reach of ASTAGRAF XL?

ASTAGRAF XL has been approved for use in 73 countries[1][4].

How does ASTAGRAF XL contribute to Astellas Pharma's revenue?

ASTAGRAF XL is part of the broader PROGRAF product category, which contributes significantly to Astellas' revenue. However, specific sales figures for ASTAGRAF XL are not typically reported separately[3].

Sources

1. ASTAGRAF XL (tacrolimus extended-release capsules), Prophylaxis of Organ Rejection in Adult Kidney Transplant Recipients, Now Available from Astellas. Astellas Pharma US, Inc.
2. Q2/FY2022 FINANCIAL RESULTS. IR Webcasting.
3. Annual Report 2021. Astellas Pharma Inc.
4. ASTAGRAF XL™ (tacrolimus extended-release capsules) Prophylaxis of Organ Rejection in Adult Kidney Transplant Recipients Now Available from Astellas. PR Newswire.
5. Financial Results of Astellas for the First Nine Months of FY2023. Astellas Pharma Inc.